BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FLAME PHOTOMETER STANDARD

    K Number: K860501 · Decision Apr 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    40
    Review Days
    55

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    Basic Information

    Device Name
    FLAME PHOTOMETER STANDARD
    K Number
    K860501
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1315
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Medical Specialties, Inc.
    Date Received
    February 11, 1986
    Decision Date
    April 7, 1986
    Product Code
    JLJ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JLJ Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate

    Other Clearances by Medical Specialties, Inc.

    K Number Device Name
    K946201 STAND, INFUSION
    K931947 CHECKPOINT
    K926095 REFRACTROL-SP
    K924926 MSI-HCT
    K896566 MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE
    K883703 MSI-CAL 7
    K883851 MSI-CAL 8
    K883850 MSI-CAL 16
    K880608 MSI-PC
    K880270 MSI-DIFF PLUS
    Search all 40 clearances from Medical Specialties, Inc. →